Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances
Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
1 other identifier
interventional
160
1 country
1
Brief Summary
In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. May treatment be improved with customized archwires? Study hypotheses:
- By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
- The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMarch 30, 2009
March 1, 2009
3 years
March 27, 2009
March 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of the orthodontic treatment (overall and every appointment)
every 6 weeks until the end of the treatment
Secondary Outcomes (2)
Quality measured using a quality index (ABO-Score)
Amount of root resorption comparing x-rays before and after the treatment
Study Arms (2)
1
EXPERIMENTALCAD/CAM group, customized archwires
2
ACTIVE COMPARATORprefabricated archwires (superelastic)
Interventions
orthodontic treatment with customized archwires
orthodontic treatment with prefabricated archwires
Eligibility Criteria
You may qualify if:
- treatment with fixed orthodontic appliances is indicated
- complete secondary dentition
- age: 11-30
- in good general health
- patient is informed about study and agrees to participate
You may not qualify if:
- syndromes affecting bones and teeth
- cleft lip and palate
- inflammation or reduction (more than 50%) of periodontium
- intake of drugs affecting tooth movement and bone formation
- disturbance of bone formation
- disturbance of thyroidal function
- pregnancy
- participation in additional study affecting oral hygiene
- former therapy with ionized radiation or cytostatic drugs
- caries (active phase)
- alcohol dependency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Berlin, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul-Georg Jost-Brinkmann, Prof
Charite - Universitätsmedizin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
March 1, 2007
Primary Completion
March 1, 2010
Study Completion
October 1, 2010
Last Updated
March 30, 2009
Record last verified: 2009-03